Table 2.
All serious and non-serious adverse events are provided in this table, additionally indicating time of manifestation, disease entity of the affected patient, necessity of treatment discontinuation due to the event and correlation to the drug due to the study team’s discretion.
| Patient no. | Serious adverse event | Point of onset (week) | IBD | Discontinuation of therapy | Drug-related event |
|---|---|---|---|---|---|
| 8 | Hepatic metastasis of a neuroendocrine tumour | 4 | UC | Yes | Possibly related |
| 53 | Bowel resection for inflammatory stenosis | 24 | CD | Yes, but for SLR | Not related |
| 89 | Hospitalization for acute flare | 9 | CD | Yes, but for SLR | Not related |
| 29 | Staphylococcus aureus sepsis | 24 | CD | Yes | Possibly related |
| 94 | Hospitalization for diarrhoea-associated hypopotassaemia | 41 | CD | No | Not related |
| 65 | Surgery for scoliosis | 57 | CD | No | Not related |
| 91 | Traumatic subarachnoid haemorrhage | 12 | UC | No | Not related |
| Patient no. | Non-serious adverse event | Point of onset (week) | IBD | Discontinuation of therapy | Drug-related event |
| 1 | Arthralgia | 26 | UC | No | Not related |
| 2 | Arthralgia | 34 | CD | No | Not related |
| 5 | Arthralgia | 18 | UC | No | Not related |
| 7 | Arthralgia | 17 | UC | No | Not related |
| 9 | Arthralgia | 52 | CD | No | Not related |
| 11 | Arthralgia | 12 | CD | No | Not related |
| 12 | Arthralgia | 16 | UC | No | Not related |
| 16 | Arthralgia | 19 | CD | No | Not related |
| 18 | Arthralgia | 32 | CD | No | Not related |
| 39 | Arthralgia | 25 | CD | No | Not related |
| 52 | Arthralgia | 25 | UC | No | Not related |
| 53 | Arthralgia | 20 | CD | No | Not related |
| 58 | Arthralgia | 20 | CD | No | Not related |
| 61 | Arthralgia | 20 | CD | No | Not related |
| 67 | Arthralgia | 36 | UC | No | Not related |
| 6 | Spondyloarthropathy | 52 | UC | No | Not related |
| 52 | Enthesitis | 49 | UC | No | Not related |
| 94 | Gout | 37 | CD | No | Not related |
| 6 | Cephalalgia | 13 | UC | No | Not related |
| 2 | Axillary abscess | 14 | CD | No | Possibly related |
| 37 | Respiratory infection | 57 | CD | No | Possibly related |
| 39 | Respiratory infection | 51 | CD | No | Possibly related |
| 35 | Thrush oesophagitis | 24 | CD | No | Possibly related |
| 60 | Erysipelas | 27 | CD | Yes, but for SLR | Possibly related |
| 63 | Herpes zoster | 32 | UC | No | Possibly related |
| 66 | Acute tonsillitis | 25 | UC | No | Possibly related |
| 69 | Otitis media | 57 | CD | No | Possibly related |
| 67 | Mastitis | 20 | UC | No | Possibly related |
| 2 | Uveitis | 49 | CD | No | Not related |
| 11 | Episcleritis | 47 | CD | No | Not related |
| 21 | Conjunctivitis | 35 | CD | No | Not related |
| 35 | Conjunctivitis | 30 | CD | No | Not related |
| 50 | Conjunctivitis | 60 | CD | No | Not related |
| 92 | Conjunctivitis | 14 | CD | No | Not related |
| 35 | Scleritis | 36 | CD | No | Not related |
| 39 | Adverse skin reaction | 33 | CD | No | Certainly related |
| 29 | Adverse skin reaction | 16 | CD | No | Certainly related |
| 44 | Adverse skin reaction | 8 | UC | No | Certainly related |
| 67 | Adverse skin reaction | 56 | UC | No | Certainly related |
| 69 | Adverse skin reaction | 8 | CD | No | Certainly related |
| 75 | Adverse skin reaction | 5 | CD | No | Certainly related |
| 22 | Erythema | 18 | CD | No | Possibly related |
| 57 | Perioral dermatitis | 25 | CD | No | Possibly related |
| 73 | Anaphylactic infusion reaction | 40 | CD | Yes | Certainly related |
| 76 | Anaphylactic infusion reaction | 0 | UC | Yes | Certainly related |
| 15 | Anaphylactic infusion reaction | 0 | UC | No | Certainly related |
| 51 | Hepatitis of unknown origin | 55 | CD | No | Possibly related |
| 51 | Gilbert’s syndrome | 50 | CD | No | Not related |
| 62 | Perianal abscess | 17 | CD | No | Not related |
| 62 | Perianal fistula | 31 | CD | No | Not related |
| 4 | IgA nephropathy | 48 | CD | No | Possibly related |
| 22 | Nephrolithiasis | 35 | CD | No | Not related |
| 48 | Nephrolithiasis | 54 | CD | No | Not related |
| 14 | Multinode struma | 16 | UC | No | Not related |
| 32 | Tinnitus | 19 | CD | Yes, but for SLR | Not related |
| 45 | Missed abortion | 11 | CD | No | Not related |
| 64 | Gastritis | 12 | CD | No | Not related |
| 67 | Reflux | 48 | CD | No | Not related |
| 91 | Anaemia | 12 | UC | No | Not related |
CD, Crohn’s disease; IBD, inflammatory bowel disease; SLR, secondary loss of response; UC, ulcerative colitis.